Category: DEA

Note from Vince:This is am extremely important change as the Cannabis grown by NIDA is an uncommon variety and apparently low in THC. The FDA could approve a Medical Study of the use of high THC Cannabis in the treatment of Cancer, but NIDA always had the final word. If they approved a medical study (their usual common response was “No”) the study had to use the NIDA supplied Cannabis variety.

WASHINGTON, D.C. — Today, the Drug Enforcement Administration (DEA) announced their intention to grant licenses to additional marijuana growers for research, thereby ending the DEA-imposed 48-year monopoly on federally legal marijuana. Since 1968, the University of Mississippi, under contract to the National Institute on Drug Abuse (NIDA), has maintained the only facility in the United States with federal permission to grow marijuana for research.

“It’s a complete and total end of the NIDA monopoly! There has been no production monopoly on any other Schedule I substance, like MDMA or LSD—only the cannabis plant. Licensing non-government cannabis producers, and thereby creating a path to FDA approval, will finally facilitate the removal of marijuana from Schedule I, and ultimately allow patients to receive insurance coverage for medical marijuana,” said Rick Doblin, Ph.D., Founder and Executive Director of the Multidisciplinary Association for Psychedelic Studies (MAPS).

MAPS has been working to eliminate this cannabis research blockade since 1999. NIDA’s marijuana is eligible for research, but cannot be sold as a prescription medicine, making it unacceptable to the Food and Drug Administration (FDA) for use in future Phase 3 studies. Ending the monopoly finally allows for a pathway to FDA approval for marijuana, which would thereby trigger rescheduling.

In 2001, MAPS partnered with University of Massachusetts-Amherst Professor Lyle Craker, Ph.D., to apply for a DEA license and end the monopoly. In 2007, after years of bureaucratic delays and lengthy legal hearings, a DEA Administrative Law Judge (ALJ) recommended that it would be in the public’s interest to grant Craker the license. In 2009, after almost two more years of delays and less than a week before the inauguration of President Obama, former DEA Administrator Michelle Leonhart rejected the ALJ recommendation. In 2011, Craker sued the DEA in the U.S. First Circuit Court of Appeals. In its 2013 decision, the Court uncritically accepted the DEA’s arguments that NIDA’s monopoly provided “an adequate supply produced under adequately competitive conditions.”

Since the 2013 decision, Craker’s argument that NIDA does not have an adequate supply has become significantly more apparent. NIDA has been unable to provide the strains requested for MAPS’ long-delayed Phase 2 clinical trial of smoked marijuana to treat symptoms of posttraumatic stress disorder (PTSD) in 76 U.S. veterans. As a result, the study is proceeding with lower potency marijuana than what MAPS researchers requested.

The DEA has previously claimed that U.S. international treaty obligations under the United Nations Single Convention on Narcotic Drugs (Single Convention) require a federal monopoly, but in April 2016, the State Department released a statement clarifying that the Single Convention does not in fact limit the number of U.S. marijuana producers.

Furthermore, the DEA’s 2009 rejection of the ALJ recommendation to license Craker relied heavily on a U.S. Department of Health and Human Services (HHS) protocol review process, which was eliminated in 2015.

MAPS’ upcoming Phase 2 clinical trial of marijuana for PTSD in veterans is in collaboration with investigators in Phoenix, Arizona, and at Johns Hopkins University, the University of Colorado, and the University of Pennsylvania. The study is funded by a $2.15 million grant to MAPS from the State of Colorado. The study has received full regulatory approval, and will be the first randomized controlled trial of whole plant marijuana as a treatment for PTSD.

Founded in 1986, MAPS is a non-profit research and educational organization working to evaluate the safety and efficacy of botanical marijuana as a potential prescription medicine for specific medical uses approved by the FDA.

Founded in 1986, the Multidisciplinary Association for Psychedelic Studies (MAPS) is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana.

Copyright

If a specific photo is not our own, we will include a Photo Credit just below the photograph in the Caption area. Any such photos are either in the Public Domain, carry a Creative Commons license for Free use or are used with permission granted by said Copyright Holder.

Videos are linked to only when the originating Video site permits us to do so. The vast majority of linked to videos found on this site are courtesy of YouTube and assorted YouTube Channels.

Affiliations & Disclaimer

Uniquely Toronto and this blogsite are not affiliated with the City of Toronto, in any way.

The City of Toronto does "not" sponsor or endorse the Uniquely Toronto blog, or the Photos and Blog Posts found here.

****************
DISCLAIMER:
****************
All the articles on this site are for entertainment, educational and commentary purposes only, and as such are protected by Laws governing Free Speech. They are not intended to provide, nor replace, medical, health, legal, financial or other professional advice. Each person visiting our site must do their own Due Diligence and always speak with their own Licensed Medical and or Licensed Financial Professional.

In 2017 I have started to post about Medical Cannabis. FDA Disclaimer: The statements on this site have not been evaluated by the US FDA and are not intended to diagnose, treat, cure or prevent any disease.

Your Licensed Medical Doctor must be consulted before
starting any form of treatment.

The information which is posted on the Uniquely Toronto blog should NEVER be considered as being professional medical advice. Vincent Banial is not a Licensed Medical Doctor. As was mentioned earlier in this Disclaimer, all the articles on this site are for entertainment, educational and commentary purposes only.

Anything posted on this Blog is subject to change without notice. I report on events over which I have no control. Stuff happens and things are always subject to change without notice (like life itself).

No endorsement of products and services found in our photos or mentioned in our blog posts is either expressed or implied.

Blog posts may contain unintentional errors and or omissions. Please inform me of any errors that you may find on the blog. Our email address is at the top of the blog.

All posts are for entertainment, educational and commentary purposes only, and as such are protected by Laws governing Free Speech.

Trademarks

Product names, brands, logos and any other trademarks found in our Photos or referred to within our Blog posts, are the property of their respective trademark holders. Any Trademarks found and are not used here for commercial purposes. The trademark owners are not affiliated with Vincent Banial, or the Uniquely Toronto blog, or the Uniquely Tech blog, or the Unique F-Stop blog, or the CLiK CLiK Vic photo site. The trademark owners do "not" sponsor or endorse our Photos or Blog Posts

Published under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0 license

The licensor cannot revoke these freedoms as long as you follow the license terms.

Under the following terms:

Attribution — You must give appropriate credit to Vincent Banial, provide a link back to https://uniquelytoronto.wordpress.com, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.

NonCommercial — You may not use the material for commercial purposes.

NoDerivatives — If you remix, transform, or build upon the material, you may not distribute the modified material.

No additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.

Notices:

You do not have to comply with the license for elements of the material in the public domain or where your use is permitted by an applicable exception or limitation.

No warranties are given. The license may not give you all of the permissions necessary for your intended use. For example, other rights such as publicity, privacy, or moral rights may limit how you use the material.